Stanford APBI Trial
Clinical Trial
Overview
Intraoperative Radiotherapy (IORT) is one of three approaches used for accelerated, partial breast irradiation at Stanford.
Accelerated, partial breast irradiation (APBI) is a potentially important new way to incorporate radiotherapy in the treatment of women with breast cancer.
Currently, women with breast cancer who undergo a lumpectomy typically have 6 1/2 weeks of radiation to the entire affected breast after surgery. Accelerated, partial breast irradiation (APBI) changes this approach in two ways. It shortens the treatment time from 6 1/2 weeks to between 1 to 5 days, and reduces the treatment area from the entire breast to the area of the breast immediately around the lumpectomy site. This is the part of the breast where most cancers are likely to recur.
In many ways APBI is to current whole breast radiotherapy what a lumpectomy is to a mastectomy. The goal is to use a less invasive more focused treatment without compromising survival.
APBI has been used in limited trials in several hundred patients over the last 10 years. These trials show that in properly selected breast cancer patients APBI worked just as well as whole breast radiotherapy. In the initial studies, investigators relied on the placement of many catheters in the breast tissue (interstial brachytherapy). Newer techniques will hopefully provide the same good results but will deliver the radiation in faster and/or more convenient ways. This could increase interest in APBI and allow additional clinical trials that test the safety and effectiveness of the newer approaches. These newer approaches could increase quality of life for many women with breast cancer.
Investigators at Stanford University Medical Center are currently offering an IRB approved clinical trial that uses three new approaches for APBI. These three approaches are:
Intraoperative Radiotherapy (IORT) - 1 day
Intracavitary Brachytherapy (MammoSite) - 5 days
3-D Conformal/External Beam Radiotherapy - 5 days
The Stanford trial is led by Dr. Frederick Dirbas, Assistant Professor of Surgery, and by Dr. Donald Goffinet, Professor of Radiation Oncology. For further information about the trial please contact Janelle Maxwell or Triona Dolphin at (650) 498-7740.
A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes
The purpose of this study is to evaluate the safety, tolerability, and preliminary clinical activity of CC-95251 alone and in combination with antineoplastic agents in participants with relapsed or refractory acute myeloid leukemia and relapsed or refractory and treatment-naive higher risk melodysplastic syndromes.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: CC-95251
- drug: Azacitidine
- drug: Venetoclax
Eligibility
Inclusion Criteria:
• Eastern Cooperative Oncology Group Performance Status of 0 to 2
For Parts A & B:
- Relapsed or refractory (R/R) acute myeloid leukemia (AML) as defined by the 2016 WHO
Classification
- R/R myelodysplastic syndromes (MDS) as defined by the 2016 WHO Classification with
intermediate, high or very high risk by Revised International Prognostic Scoring
System (IPSS-R)
For Part C:
• Treatment-naïve (TN) (ie, previously untreated) MDS as defined by the 2016 WHO
Classification with intermediate, high or very high risk by IPSS-R
For Part D:
• TN AML as defined by the 2016 WHO Classification, including secondary AML and
therapy-related AML in participants who are ineligible (IE) for intensive chemotherapy (IC)
and allogeneic hematopoietic stem cell transplant (HSCT)
Exclusion Criteria:
- Acute promyelocytic leukemia
- Immediately life-threatening, severe complications of leukemia such as
disseminated/uncontrolled infection, uncontrolled bleeding, and/or uncontrolled
disseminated intravascular coagulation
- Participants who have received prior treatment with a CD47 or SIRPα targeting agent
- Participant is on chronic systemic immunosuppressive therapy or corticosteroids
- Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half-lives
or 4 weeks prior to starting study treatment, whichever is shorter (relapsed or
refractory participants only).
- Any condition including, active or uncontrolled infection, or the presence of
laboratory abnormalities, which places the participant at unacceptable risk if he/she
were to participate in the study
- Pregnant or nursing participants.
Other protocol-defined inclusion/exclusion criteria apply
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Ji Hyun Choi
+1 650-723-1367
I'm interested
What's New
Stanford’s APBI trial has now been expanded to include women with ductal carcinoma in situ (DCIS). Please call 650-498-7740 for more information.